Kornimate/medical-research-clean huggingface dataset:
ravulizumab in pregnancies complicated by severe hypertensive disorders

Conditions: Preeclampsia

Summary: the researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and hemolysis, elevated liver enzymes, low platelets (hellp) syndrome.


Eligibility criteria:
inclusion criteria: * individuals with \< 34 0/7 weeks of gestation. * individuals with severe preeclampsia or hellp features. exclusion criteria: * pregnant female patients presenting with disseminated intravascular coagulopathy (dic). * individuals with non-reassuring fetal status requiring delivery, non-viable fetuses, previable pregnancy (\<23 0/7 weeks gestation), stroke, in utero fetal demise, known atypical hemolytic uremic syndrome, familial or acquired thrombocytopenia purpura, paroxysmal nocturnal hemoglobinuria, allergy to ravulizumab, inability or unwillingness to sign informed consent.

Keywords: hemolysis elevated liver enzymes low platelets
decitabine plus carboplatin in the treatment of metastatic tnbc

Conditions: Breast Neoplasm

Summary: to evaluate the effect of novel dna demethylating agents in the treatment of metastatic tnbc


Eligibility criteria:
inclusion criteria: * female aged between 18 years and 70 years old. * pathologically confirmed metastatic triple negative breast cancer (tnbc). paraffin-embedded tissue were available from metastatic or primary sites to confirm its tnbc status or for further translational research. tnbc was defined as er-, pr-, and her2-. * metastatic tnbc should not be treated with more than 1-line for metastatic disease. * patients can not be treated with carboplatin in the metastatic setting. * for patients received carboplatin treatment in the adjuvant setting, they should have at least one year disease interval between last dosage of carboplatin and trial recruiting. * patients had at least one measurable lesion according to recist criteria version 1.1. * ecog performance status (ps) of 0-1. * adequate liver and renal organ function. * dated and signed iec/irb-approved informed consent. exclusion criteria: * more than 1 one therapy for metastatic tnbc, patients may receive bisphosphonates and other therapies to treat bone metastases. * less than four weeks since last radiotherapy. * pregnancy or lactation or unwillingness to use adequate method of birth control. * active or uncontrolled infection. * hypersensitivity to carboplatin or decitabine * male breast cancer. * treated with any dna demethylating agents * young patients with pregnancy or lactation or unwillingness to use adequate method of birth control.

Keywords: decitabine triple negative breast cancer carboplatin metastatic
long term evaluation of clinical and radiologic results on femoro-patellar joint after high tibial osteotomy

Conditions: Knee Osteoarthritis; Deformity Knee

Summary: osteotomies are among the oldest orthopedic treatments, in use for over 2000 years and still commonly employed. the basic principle involves making a bone cut to allow the realignment of the limb segment affected by deformity. today, new knowledge and technologies, understanding of bone healing mechanisms, and the introduction of new fixation methods have made osteotomies one of the preferred treatments for early knee arthritis. they serve as an alternative to joint prosthesis implantation in young patients with medium to high functional demand. medial knee osteoarthritis is a pathology increasingly prevalent in today's population. the resulting varus deformity leads to a shift in the load axis on the medial tibial plateau. osteotomy in this context becomes a therapeutic tool capable of restoring the correct mechanical axis of the lower limb and delaying or avoiding the progression of arthritis, thus avoiding the need for joint replacement. the two most commonly used techniques are the closing wedge lateral high tibial osteotomy (lcw-hto) and the opening wedge medial high tibial osteotomy (mow-hto), which are high tibial osteotomies in closure with a wedge removal and in opening with a wedge insertion, respectively. the medium to long-term effects of this procedure, in terms of survival and modification of the tibial slope, have been extensively studied, as evidenced by the extensive literature on the subject. however, the effect of this intervention, in its two variants, on the progression of femoro-patellar arthritis and the height of the patella remains poorly investigated to date.


Eligibility criteria:
inclusion criteria: 1. diagnosis of medial unicompartmental knee osteoarthritis (outerbridge iii-iv) 2. follow-up \> 60 months 3. completeness of clinical and radiographic documentation. 4. previous valgus osteotomy procedure (mow-hto or lcw-hto) 5. age \<65 years exclusion criteria: 1. patients with previous injuries affecting the involved lower limb. 2. patients with prior traumatic, septic, and rheumatoid arthritis. 3. patients with previous alterations of the patellofemoral joint. 4. patients with knee ligament injuries. 5. patients with confirmed neuromuscular disorders or psychomotor disturbances. 6. patients with congenital generalized hypermobility syndrome. 7. patients with severe pathologies in other organs or systems limiting activities of daily living (adl). 8. patients who refuse to participate in the study.

Keywords: knee osteotomy high tibial osteotomy
safety, tolerability, pharmacokinetics and pharmacodynamics of hms5552 in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the objectives of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of hms5552 following multiple ascending doses in patients with type 2 diabetes mellitus.

this will be a randomized, double-blind and placebo-controlled study with multiple oral doses of hms5552 given to patients with type 2 diabetes mellitus who never accepted anti-diabetic drug for treatment before. the primary objective is to characterize the safety and tolerability of hms5552 following multiple ascending doses in patients with type 2 diabetes mellitus after bid dosing for 8 days. the secondary objectives include: 1. to determine the single dose and steady state pharmacokinetics of hms5552 in patients with type 2 diabetes 2. to evaluate the single dose and steady state pharmacodynamics of hms5552 in patients with type 2 diabetes 3. to further explore food-effect on hms5552 pharmacokinetics and pharmacodynamics a maximum total of 80 patients (10 in each dose group and assuming a maximum of 5\~8 dose levels). there will be 8 active and 2 placebo patients in each dose group. the safety, tolerability, pharmacokinetics and pharmacodynamics data after each dose cohort will be reviewed in blinded fashion before escalation to the next dose cohort.

Eligibility criteria:
inclusion criteria: * male and female subjects with type 2 diabetes * age: 18 to 65 years * bmi: 20 to 29 kg/m2 * mentally, physically and legally eligible to give informed consent. * willingness to adhere to the protocol requirement. exclusion criteria: * subjects with type 1 diabetes * episodes of hypoglycemia * unstable cardiovascular diseases * hepatic diseases * kidney disease * mental or central nervous system diseases * clinical abnormal findings in ecg, labs and physical exams

Keywords: glucokinase activator phase i type 2 diabetes mellitus
smartphone-based mindfulness training for chronic pain

Conditions: Chronic Pain

Summary: the purpose of this study is to test a smartphone-based mindfulness training program for chronic pain. research participants use a 20 minute app-guided audio program six days per week. the study hypothesis is that training in this technique over a period of four weeks will reduce pain interference with daily life activities. this study does not require any travel or in-person contact with research staff-- all elements of the study are completed on the participant's smartphone.

this is a randomized, waitlist controlled trial. smartphone users who download the research app complete an electronic informed consent before the app content is made available. subjects meeting inclusion criteria are then prompted to complete baseline questionnaires. submission of questionaires triggers randomization to one of two groups-- active treatment or waitlist. subjects have equal chance of entering either group. the active treatment group is instructed to use the app-guided "body scan" exercise daily for six days per week. the waitlist group is instructed that the research intervention will be made available to them in four weeks time. on a weekly basis, all subjects complete a brief pain inventory scale. at the end of four weeks, subjects again complete a brief pain inventory as well as the questionnaires measuring secondary outcomes. upon completion of the control condition, waitlist subjects are invited to begin using the "body scan" exercise as described above. from this point forward, subjects receive the same protocol as the active treatment group. this study involves no face-to-face contact between participants and study investigators/staff.

Eligibility criteria:
inclusion criteria: * english speaking * pain duration at least 3 months * access to smartphone exclusion criteria: * pain from active cancer * pain from active cardiac disease

Keywords: chronic pain mobile applications mindfulness meditation telemedicine cellular phone pain management therapy, computer-assisted
schistosomiasis effect on response to vaccines, anaemia and nutritional status of children of northern senegal

Conditions: Schistosomiasis; Anemia; Underweight; Stunting; Intestinal Parasites

Summary: schistovan aims to study the role of schistosomiasis infection in the modulation of the immune response of children to childhood vaccine antigens, as well as the impact of this infection on their nutritional status and their haemoglobinaemia.

schistovan aims to study the interactions between chronic parasite infections such as schistosomiasis and the immunological and nutritional status of children. in this scope, the investigators conducted a case-control study where one group of children is infected with schistosoma haematobium and the other is not infected with this parasite. the investigators then stimulated whole blood of these children with various vaccine antigens to address their immune function and study the influence of schistosomiasis infectious state on their overall immune condition. aims of the study: to evaluate the interaction between schistosomiasis and the nutritional status of children and their haemoglobinemia. to evaluate the influence of schistosomiasis on children's specific immune response towards epi vaccine antigens, the inflammatory status of children and nutritional serologic markers. to compare schistosomiasis diagnostic tools (evaluation of circulating cathodic antigen (cca) strip for diagnosis of urinary schistosomiasis in comparison with microscopy and urinary dipsticks) to study prevalence of intestinal parasites such as blastocystis hominis

Eligibility criteria:
inclusion criteria: * members of anopalanovac cohort * age: between 6 and 10 years exclusion criteria: * body temperature \> 38.5 ºc * malaria episode

Keywords: schistosoma haematobium schistosoma mansoni anemia underweight stunting blastocystis
arterial stiffness and complication risk in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Diabetes Complications; Diabetic Angiopathies; Diabetic Nephropathies

Summary: background the prevalence and incidence of type 2 diabetes is increasing globally. a common complication of diabetes is the disease of the blood vessels, vascular diseases, which can cause disorders like myocardial infarction, stroke and kidney failure. methods to detect early subclinical stages of macro-vascular disease are not yet available in a clinical setting. hypothesis arterial stiffness, an easy accessible vascular parameter, may provide additional prognostic information when evaluating risk profile for patients with diabetes type 2. aim the aim of the project is to investigate the association between arterial stiffness and the occurrence and development of vascular complications in patients with type 2 diabetes. specifically we want to investigate: 1. in a cross-sectional study, the association between arterial stiffness and subclinical atherosclerotic changes in the coronary arteries assessed by computed tomography (ct) and 2. in a longitudinal study, the predictive value of arterial stiffness on the development of subclinical cerebrovascular changes assessed by magnetic resonance imaging (mri) and nephropathy assessed by urine analysis. methods the study population consists of 100 patients with newly diagnosed type 2 diabetes and 100 age- and sex matched controls. the study participants were enrolled between 2008-2011 and extensively characterized i.a. with arterial stiffness (pulse wave velocity), mri (white matter lesions and cerebral infarctions) and urine analysis (albuminuria). in this study we will enrol the same patients in a 5 year follow-up study in order to repeat above mentioned measurements. furthermore, ct is used to investigate the coronary plaque burden of the participants (agatston score and segment involvement score). results and perspective this project adds new insight into arterial stiffness as a predictor of the progression of micro- and macrovascular complications in patients with type 2 diabetes, and can potentially improve risk stratification and early strategies of intervention in this patient group.


Eligibility criteria:
inclusion criteria: * 18 years of age * diabetes, type 2, diagnosed within 5 years from baseline (cases) exclusion criteria: * non-diagnosed diabetes (healthy controls) * acute or chronic infectious diseases * kidney failure (requiring dialysis) * pregnancy/breastfeeding * prior or concomitant cancer disease * contraindication for mri (claustrophobia, magnetic implants or bodyweight above 120kg) * contraindication for ct (estimated glomerular filtration rate \ 35 kg/m2, heart arrhythmia, heart failure, aorta stenosis, contraindications for beta blockage or nitroglycerin or failure to cooperate)

Keywords: diabetes mellitus, type 2 diabetes complications diabetic angiopathies diabetic nephropathies myocardial infarction stroke vascular stiffness pulse wave analysis
covid-19 health professional impact study

Conditions: Coronavirus Infection; Severe Acute Respiratory Syndrome

Summary: the covid-19 (coronavirus) pandemic has had a huge impact on healthcare resources and staff in the uk. understanding the key risk factors associated with infection amongst healthcare workers is essential for future pandemic response plans. currently there are scarce data relating to the infection rates and associated factors amongst healthcare workers in the united kingdom (uk). studies of infection rates in healthcare workers have largely relied on the real-time reverse transcriptase-polymerase chain reaction (rt-pcr) test to date and it appears that healthcare workers are twice as likely to succumb to coronavirus infection, when compared to the general population and those from black and minority ethnic (bame) backgrounds appear to be particularly at risk. currently there is no evidence that the presence of sars-cov-2 (severe acute respiratory syndrome coronavirus 2) antibodies provides seasonal or long term immunity to future infection. therefore, this study aims to understand the current level of sars-cov-2 antibody positivity and try to determine the likely risk to healthcare workers in the uk to covid-19 infection. this study hopes to find out whether certain individual characteristics will have an impact on likelihood of infection susceptibility and antibody response and determine the impact of the presence of antibodies on the likelihood of future clinical infection over a 12 month period. the study involves an initial online survey and linkage to the recent antibody test, then a further online survey in 6 and 12 months' time. the data obtained will be linked to data that the human resources department (hr) holds. participants also have the option to partake in another antibody test at 6 and 12 months' time and linked to the data collected.

participants will have access to the study via the link given in an sms (short message service - text message) which will direct then to the first online survey. they will then be contacted again in 6 and 12 months' time to complete the online survey again. the survey answers will be linked to the results of the antibody tests by their mobile and employment number and also to data held about them by the hr department. the survey will take approximately 15 minutes to complete and will include questions on the following: profession; work-line type; demographics and behavioural factors; ethnicity; and symptoms (if covid 19 was manifested). participants can also attend for another blood test (sars-cov-2 (severe acute respiratory syndrome coronavirus 2) antibody test) to detect any presence of antibodies at 6 and 12 months (optional) which will again be linked to the survey and hr data.

Eligibility criteria:
inclusion criteria: * all staff employed by royal wolverhampton trust, having undergone the sars-cov-2antibody test at the trust's testing facility exclusion criteria: * royal wolverhampton nhs trust staff who have not participated in antibody testing • staff who have opted out to receiving the text message invite and be part of the study
a study to evaluate the safety and efficacy of pf-06650833, pf-06700841, and pf 06826647 in adults with hidradenitis suppurativa

Conditions: Acne Inversa

Summary: this is a study with 3 kinase inhibitors (pf 06650833, pf 06700841 and pf 06826647) in participants with moderate to severe hs. the study will have a maximum duration of approximately 26 weeks. this includes an up to 6-week screening period, a 16 week dosing period and a 4 week follow up period.


Eligibility criteria:
inclusion criteria: * male or female participants, between 18-75, with a diagnosis of moderate to severe hidradenitis suppurativa exclusion criteria: * history of human immunodeficiency virus (hiv) or positive hiv serology at screening, * infected with hepatitis b or hepatitis c viruses. * have evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (tb)
stereotactic radiotherapy of prostate cancer with reduction of safety margins

Conditions: Prostate Cancer (Adenocarcinoma)

Summary: the study aims to reduce the ptv (planning target volume) safety margins to 1-2 mm in stereotactic prostate radiotherapy for low- and medium-risk prostate cancers while maintaining a dose of 36.25 gy in 5 fractions per day. by reducing the hems, the investigators expect a reduction of acute and late toxicity on the organs at risk, dominantly the urethra, bladder, penile bulb, and rectum, and an improvement in the quality of life.

in this prospective study, a total of 100 patients will be treated over 2 years. patients will be implanted with 4 contrast markers (fiducials) in the prostate - in the base, apex, and right and left lobes of the prostate. subsequently, 3 planning examinations will be performed: 1. ct with a urinary catheter immediately after the implantation of fiducials (gold contrast markers), with a distance from implantation 2. planning ct and mr without a urinary catheter. the ctv (clinical target volume) will be defined by the prostate, and the border on the ptv will be reduced from 3-5 mm to 1-2 mm isometrically to maximize the reduction of doses to the organs at risk (rectum, bladder, and urethra, penile bulb, testes), the organs at risk (oar) will be marked in the radiation plan as oar. subsequently, the patients will be irradiated with a dose of 36.25 gy in 5 fractions per day. acute toxicity will be evaluated in the 1st and 3rd month after radiotherapy, and late toxicity after 4-6 months according to ctcae criteria (common terminology criteria for adverse events).

Eligibility criteria:
inclusion criteria: * histologically verified, localized prostate cancer without regional lymphadenopathy or distant metastases * low or intermediate risk - favorable risk * staging according to nccn recommendations: * low risk: no staging required * intermediate risk- favorable risk: ct abdomen and pelvis * psa up to 15 * age over 18 years * signed informed consent form * suitable position of fiducials (to be determined by the physicist) exclusion criteria: * a histological type other than acinar adenocarcinoma * the presence of local lymphadenopathy or distant metastases * a dominant lesion in the periphery that is in contact with the capsule or grows through it * psa over 15 * unsatisfactory position of fiducials (to be determined by the physicist) * previous treatment with radiotherapy to the pelvic area

Keywords: prostate cancer stereotactic body radiotherapy acute toxicity late toxicity
study of the ons "nutrinidrink with dietary fiber" use effect on some health indicators in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: the goal of this low-interventional study was to study the effect of additional nutritional support with ons "nutrinidrink with dietary fiber" on the anthropometric parameters of patients and the dynamics of gastrointestinal symptoms in patients with cerebral palsy. among the additional objectives were to study the quality of life, metabolic parameters and the dynamics of some functional parameters of patients. possible adverse events were also studied and described.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cerebral palsy, spastic and hyperkinetic forms; * class of cerebral palsy gmfcs 2-3; * z-score bmi ≤ -1; * the patient's ability to safely swallow liquid food; * availability of informed consent signed by the patient's legal representative for inclusion in the study and processing of personal data. exclusion criteria: * individual intolerance to the investigational product components; * galactosemia; * allergy to cow's milk proteins and other food intolerances; * participation in another clinical study currently or in the past 30 days; * any other medical or non-medical reason that, in the physician's opinion, may prevent the patient from participating in the study. * deterioration of the patient's condition requiring his transfer to enteral or parenteral nutrition; * transfer of a patient to another hospital; * complications that could be caused by the investigational product (diarrhea, nausea, vomiting, allergies, etc.); * withdrawal for a safety reason * refusal of the patient (his legal representative) from further participation in the study and withdrawal of informed consent to participate in the study and the processing of personal data. at the same time, the exclusion of a patient from the study should not affect the nature of his therapy

Keywords: cerebral palsy nutrition quality of life bioimpedance z-score